QA Lead Manager - GCP ONSITE Daytona Beach, Florida

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a QA Lead Manager, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

This is a full-time, office-based position in Daytona Beach, Florida.

If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

Summary of Responsibilities:

• Manages Quality Issues and CAPAs to resolution.
• Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager.
• Oversees timely completion of CAPAs and QIs in QMS.
• Supports internal and external teams in completing investigations and creation of CAPAs.
• Maintains good working knowledge of GCP and knowledge of regulatory authority requirements and inspection support.
• Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
• Supports QA lead Sr. Manager and above in pulling metric data, trending, and tracking of QIs for client metrics.
• Hosting of external audits/inspections e.g., regulatory inspections, strategic clients.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
• Experience may be substituted for education.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 5 years in regulatory environment (experience in GXP roles).
• Strong understanding of QMS and CAPA processes.
• Ability to manage client responsibilities.
• Report and communicates key quality information to Sr. Managers and QA.
• Able to work effectively within a team environment.
• Able to communicate effectively during client meetings.
• Knowledge of GCPs/GxPs.

Physical Demands/Work Environment:

• Some overtime and weekend work may be required.
• Travel required.

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Learn more about our EEO & Accommodations request here.